Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2026)
1Key Takeaways
This standard covers good clinical practice for the planning, conduct, registration, and reporting of clinical investigations involving human subjects, with the aim of evaluating the clinical performance, efficacy, and safety of medical devices. The principles outlined in this standard may be applied to post-market cli…
2Scope / Description
This standard covers good clinical practice for the planning, conduct, registration, and reporting of clinical investigations involving human subjects, with the aim of evaluating the clinical performance, efficacy, and safety of medical devices. The principles outlined in this standard may be applied to post-market clinical investigations, insofar as they are appropriate given the nature of the investigation (see Annex I).
This standard establishes general requirements aimed at:
— protecting the rights, safety, and well-being of trial participants, users, and other individuals;
— ensuring the scientific integrity of clinical investigations and the reliability of their outcomes;
— defining the responsibilities of sponsors and lead investigators; and
— assisting sponsors, investigators, ethics committees, regulatory authorities, and other parties involved in the conformity assessment of medical devices.
Other standards or national requirements may also apply to the device(s) under investigation or to the clinical investigation(s). In cases of discrepancies among requirements, the most stringent requirement shall apply.
NOTE: For software as a medical device, where appropriate, the requirements of this standard should be applied to demonstrate analytical validity (the device output is accurate for a given input), scientific validity (the device output is related to a typical clinical or physiological condition), and clinical performance (the device output provides a clinically meaningful association when used for its intended purpose). Considerations for deviating from this standard may include the uniqueness of the indirect interaction between the participant and the software as a medical device (see Reference [5]).
This standard does not apply to in vitro diagnostic medical devices. However, depending on the device and applicable national or regional requirements, users may consider applying specific provisions or requirements of this standard, or both, where appropriate.